Elisabeth Lieschke
Process Manager DSP MSAT Commercial
Experience
Process Manager DSP MSAT Commercial
- document review, change control, and CPV
- Product Quality Review
Project Manager
- revision of product information texts (labelling)
- management and maintenance of document management systems
- performing batch record reviews
- performing product quality reviews
Biopharmaceutical Quality Assurance Specialist
- Change Control
- Batch Record Review
- Site RA
Regulatory Affairs Specialist
- dossier life cycle management, CMC and labelling
- batch record review
- dossier module 2.3 and 3
- change control
Summary
Experienced regulatory affairs specialist focused on lifecycle management and pharmaceutical quality assurance in the pharmaceutical and biopharmaceutical industry
Skills
Communication
Detail-oriented Approach
Analytical Thinking
Problem-solving Skills
Adaptability And Ability To Prioritize
Flexible
Coordination, Creation, And Processing Of Change Control Requests
Review Of Dossiers (Module 2.3 And Module 3)
Creation Of Variation Notifications
Revision Of Product Information Texts (Labelling)
Management And Maintenance Of Document Management Systems
Performing Batch Record Reviews
Performing Product Quality Reviews
Document Review
Product Quality Review
Batch Record Review
Cmc
Dossier Module 2.3 And 3
Change Control
Ms Office
Veeva Vault
Webcenter Esko
Sharepoint
Trackwise
Sap
Master Control
Languages
Education
M.D.R.A. · Drug Regulatory Affairs
Bachelor · Pharmaceutical Technology
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